BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1875735 · Received October 13, 2010

    Report

    Report Number
    3004209178-2010-07926
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT. THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT'S IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE HEALTH CARE PROFESSIONAL EXPLANTED THE SYSTEM "AS PT BDP INCREASED." IT WAS ALSO DISCOVERED THAT A LEAD AND/OR EXTENSION HAD DISLODGED. THE PT RECOVERED WITHOUT SEQUELA. THE HCP INTENDED TO REPLACE THE DEVICE WITH A NEW NEUROSTIMULATOR OR A PAIN PUMP IN THE FUTURE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention LEAD: MODEL 3487A, LOT#: L63667| IMPLANTED:| IMPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL 3550-09, LOT#: LA2114| EXPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT#: UNK| STIM ACCESSORY: MODEL ANCHOR/TLOCK, LOT#: UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT#: NAF010618N| EXPLANTED: